The technical files for medical devices refer to all the documents that a medical device manufacturer has to submit to demonstrate that the product conforms to the applicable and current medical device regulations.
Technical files for medical devices shall include, e.g. a detailed description of the device and specification, reference to the previous and similar generation of the device, design information, pre-clinical testing information, clinical evaluation, and risk management of the medical device.
Technical files for medical devices shall be prepared by the medical device manufacturer and the information’s in the technical file or technical file for medical devices must be presented in a clear, organized, readily searchable, and unambiguous manner to demonstrate the safety and performance of the medical device in question.
Want to prepare a medical device technical file as per the requirement of MDR 2017/745? If your answer is yes, you probably have lots of questions about the preparation of medical device technical files such as;
We at Maven Profcon Services LLP, shall give you all the answers.
Medical device technical file shall be prepared as per the requirement of Annex II and Annex III of MDR 2017 / 745.
The technical file shall be submitted to the notified body or competent authority for review and approval for CE Certification. It should be made in the English language or the official language of an EU member state.
Under the MDR, the manufacturer shall safely store the technical documents for 10 years other than implantable device after the last device has been placed on the market, and in case of the implantable device, it should be safely stored for 15 years and non-EU manufacturer documents should be available with the Authorized Representative also.
Medical device manufacturers should be responsible for keeping the technical file up to date and in compliance with general safety and performance requirements Annex I, Annex II, and Annex III of MDR 2017/745.
| Sr. No. | Section | Description | ||||
|---|---|---|---|---|---|---|
| Section 1 General and Administrative Information. | ||||||
| 1. | 1.0 | Table of Content | ||||
| 2. | 1.1 | Technical file approval team | ||||
| 3. | 1.2 | General information for the Technical file structure including purpose, scope | ||||
| 4. | 1.3 | Company Profile | ||||
| 5. | 1.3.1 | Legal Name & Address of the Manufacture | ||||
| 6. | 1.4 | Authorized Representative name, address and contact details | ||||
| 7. | 1.5 | Notified Body Name, Number and Address | ||||
| Section 2 Technical Documentation | ||||||
| 8. | 2.1 | Device Description And Specification, Including Variants And Accessories | ||||
| 9. | 2.1.1 |
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| 10. | 2.1.1.1 | |||||
| 11. | ||||||
| 12. | ||||||
| 13. | ||||||
| 14. | 2.1.1.2 | Basic UDI-DI | ||||
| 15. | 2.1.1.3 | Intended patient populations, including details of if applicable;
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| 16. | 2.1.1.4 | Principle of operation including mode of action | ||||
| 17. | 2.1.1.5 | Rational for considering the product as medical device | ||||
| 18. | 2.1.1.6 | Device Classification and Justification for the classification rule as per Annex VIII | ||||
| 19. | 2.1.1.7 | Explanation of Novel Features | ||||
| 20. | 2.1.1.8 | Description of Accessories of device | ||||
| 21. | 2.1.1.9 | A Description of various configurations/variants | ||||
| 22. | 2.1.1.10 | General description of key components for including software where appropriate required add photograph, drawing and Diagram | ||||
| 23. | 2.1.1.11 | Description of Raw Materials | ||||
| 24. | 2.1.1.12 | Technical Specification like feature, dimension | ||||
| 25. | 2.2 | Reference of Previous and Similar Generations of the device | ||||
| 26. | 2.3 | Information Supplied by the Manufacturer | ||||
| 27. | 2.3.1 | Labels: Primary Label, Secondary label and Tertiary label
If you are selling device require specific county language then label should be available on that language |
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| 28. | 2.3.2 | Instruction for use (IFU)
If you are selling device require specific county language then IFU should be available on that language |
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| 29. | 2.4 | Design and Manufacturing Information | ||||
| 30. | 2.4.1 | Product design File | ||||
| 31. | 2.4.2 | Manufacturing process and their process validations | ||||
| 32. | 2.4.3 | Final Product Specification & Testing | ||||
| 33. | 2.4.4 | Manufacturing Environment Control | ||||
| 34. | 2.4.5 | Identified the sites including supplier & subcontractors, where design activates are performed | ||||
| 35. | 2.5 | General Safety & Performance Requirements (GSPR) | ||||
| 36. | 2.5.1 | List of Applicable Harmonized Standards, Common Specification (CS), Non-harmonized standards, applicable guidelines | ||||
| 37. | 2.5.2 | General Safety & Performance Requirements (GSPR) | ||||
| 38. | 2.5.3 | Declaration of Conformity | ||||
| 39. | 2.6 | Benefit and Risk Analysis & Risk Management | ||||
| 40. | 2.7 | Product Verification and Validation | ||||
| 41. | 2.8 | Pre-clinical and Clinical Data | ||||
| 42. | 2.8.1 | Pre-clinical and Clinical summary report | ||||
| 43. | 2.8.2 | Biocompatibility of the device | ||||
| 44. | 2.8.3 | Electrical Safety and compatibility | ||||
| 45. | 2.8.4 | Physical, Chemical & Microbiological Compatibility | ||||
| 46. | 2.8.5 | Software Verification and Validation | ||||
| 47. | 2.8.6 | Stability or self-life | ||||
| 48. | 2.8.7 | Sterilization | ||||
| 49. | 2.8.8 | Performance & Safety | ||||
| 50. | 2.8.9 | Clinical Evaluation Report | ||||
| 51. | 2.8.10 | Post Marketing Activities
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| 52. | 2.8.11 | Packaging & Transportation information | ||||
| 53. | 2.9 | Additional Information is required in specific case: | ||||
| 54. | 2.9.1 | When device incorporate a substance consider separately as medicine | ||||
| 55. | 2.9.2 | Device is manufactured by using tissue or cells of human or animal origin | ||||
| 56. | 2.9.3 | Device that are composed of substance or combination of substance | ||||
| 57. | 2.9.4 | CMR or Endocrine-Disrupting Substance | ||||
| 58. | 2.10 | Detail of Device with measuring function | ||||
| 59. | 2.11 | Details of the device to be connected to other device to achieved its intended purpose | ||||
| 60. | 2.12 | Revision History | ||||
| 61. | 2.13 | Conclusion & Approval | ||||
Our regulatory consultants in Maven who are experienced in various fields of Medical Device Regulations are well versed in taking care of technical documentation like clinical evaluation, Benefit-Risk Analysis, validations, design and development files, shelf life stability study, usability engineering files, safety and biological evaluation, and chemical characteristics evaluation.
Our regulatory consultants help you in identifying requirements as per EU MDR, identification of CE assessment route according to the class of the device, helps in clinical evaluation and also in post-marketing activities, risk analysis, and quality management implementation.
Maven as a developing medical device regulatory consultancy helps you in establishing your products in various countries with help of our experienced regulatory consultants. The below mentioned activities are taken care by us
For more details please refer our blog: https://mavenprofserv.com/technical-documentation-in-eu-mdr-745-2017/
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